每日服用50毫克米拉贝隆治疗男性膀胱过度活动症患者的疗效与安全性：五项III期研究的批判性分析
Efficacy and safety of daily mirabegron 50 mg in male patients with overactive bladder: a critical analysis of five phase III studies.
作者信息
Tubaro Andrea, Batista José E, Nitti Victor W, Herschorn Sender, Chapple Christopher R, Blauwet Mary Beth, Siddiqui Emad, Huang Moses, Oelke Matthias
机构信息
Department of Urology, Sant'Andrea Hospital, 'Sapienza' University, Via di Grottarossa 1035-1039, 00189 Rome, Italy.
Urodynamics Unit, URD/Hospital Quiron Teknon, Barcelona, Spain.
出版信息
Ther Adv Urol. 2017 May 10;9(6):137-154. doi: 10.1177/1756287217702797. eCollection 2017 Dec.
BACKGROUND
Oral pharmacotherapies to treat overactive bladder (OAB) are used less in men despite a similar prevalence of storage symptoms as women. The efficacy and safety of once-daily mirabegron 50 mg was evaluated in male OAB patients from five phase III studies that included placebo or antimuscarinic (tolterodine ER 4 mg or solifenacin 5 mg) as a comparator.
METHODS
Three pooled 12-week placebo-controlled studies (mirabegron 50 mg placebo) and one 12-week non-inferiority phase IIIb study (BEYOND; mirabegron 50 mg solifenacin 5 mg) were used for efficacy (daily micturition frequency, urgency and incontinence episodes) and safety analyses. An additional 52-week active-controlled phase III safety study (mirabegron 50 mg tolterodine ER 4 mg) was included in the safety analysis. Male patients aged ⩾18 years with OAB for ⩾3 months were included in the analyses. Patients may also have a history of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH)/benign prostatic enlargement (BPE) or concomitant use of α-blockers.
RESULTS
In the pooled studies, mirabegron 50 mg demonstrated superiority placebo (treatment difference: -0.37 [95% confidence interval (CI): -0.74, -0.01]) for reducing micturition frequency; improvements in urgency and incontinence were not significantly different between mirabegron 50 mg and placebo. In BEYOND, mirabegron 50 mg was comparable with solifenacin 5 mg for reducing micturition frequency, urgency, and incontinence episodes. Mirabegron was well tolerated at 12 and 52 weeks and overall treatment-emergent adverse events (AEs) were similar to those with placebo.
CONCLUSIONS
In a male OAB population with or without LUTS associated with BPH/BPE, mirabegron 50 mg provided similar improvements in urgency, frequency, and incontinence as solifenacin 5 mg, and is a well-tolerated alternative to antimuscarinics. In the three pooled 12-week studies, significant differences were not seen for urgency and incontinence placebo, although mirabegron 50 mg did demonstrate significant improvements placebo for frequency.
背景
尽管男性与女性膀胱过度活动症（OAB）储尿期症状的患病率相似，但用于治疗OAB的口服药物疗法在男性中的使用较少。在五项III期研究的男性OAB患者中评估了每日一次服用50mg米拉贝隆的疗效和安全性，这些研究以安慰剂或抗毒蕈碱药物（4mg缓释托特罗定或5mg索利那新）作为对照。
方法
三项汇总的为期12周的安慰剂对照研究（50mg米拉贝隆对比安慰剂）和一项为期12周的非劣效性IIIb期研究（BEYOND；50mg米拉贝隆对比5mg索利那新）用于疗效（每日排尿频率、尿急和尿失禁发作次数）和安全性分析。安全性分析纳入了另一项为期52周的活性药物对照III期安全性研究（50mg米拉贝隆对比4mg缓释托特罗定）。分析纳入了年龄≥18岁、患有OAB≥3个月的男性患者。患者可能还伴有与良性前列腺增生（BPH）/良性前列腺肿大（BPE）相关的下尿路症状（LUTS）病史或正在同时使用α受体阻滞剂。
结果
在汇总研究中，50mg米拉贝隆在降低排尿频率方面显示出优于安慰剂（治疗差异：-0.37[95%置信区间（CI）：-0.74，-0.01]）；50mg米拉贝隆与安慰剂在尿急和尿失禁改善方面无显著差异。在BEYOND研究中，50mg米拉贝隆在降低排尿频率、尿急和尿失禁发作次数方面与5mg索利那新相当。米拉贝隆在12周和52周时耐受性良好，总体治疗中出现的不良事件（AE）与安慰剂相似。
结论
在有或没有与BPH/BPE相关的LUTS的男性OAB患者群体中，50mg米拉贝隆在尿急、频率和尿失禁方面的改善与5mg索利那新相似，是一种耐受性良好的抗毒蕈碱药物替代方案。在三项汇总的为期12周的研究中，50mg米拉贝隆与安慰剂在尿急和尿失禁方面未见显著差异，尽管50mg米拉贝隆在频率方面确实显示出优于安慰剂的显著改善。
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